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13 May 2008
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| A randomised cluster controlled trial of community level interventions to address social and structural determinants of physical activity, diet and mental wellbeing |
| ISRCTN | ISRCTN68175121 |
| ClinicalTrials.gov identifier | |
| Public title | A randomised cluster controlled trial of community level interventions to address social and structural determinants of physical activity, diet and mental wellbeing |
| Scientific title | |
| Acronym | WLRCCT |
| Serial number at source | WT083679AIA |
| Study hypothesis | Are community designed interventions at Lower Super Output Area (LSOA) level effective in securing improvements in levels of healthy eating, healthy physical activity and mental health? |
| Ethics approval | Ethics approval received from the University of East London Research Ethics Committee on the 15th October 2007 (ref: ETH/07/96/0 UEL). |
| Study design | Randomised cluster controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Healthy behaviours related to diet, exercise and positive mental wellbeing |
| Participants - inclusion criteria |
1. Adult survey, resident in a sampled address within intervention or control areas over age of 16, either sex
2. Child survey, resident of the area and at school participating in survey, between 13 and 16 years old, either sex |
| Participants - exclusion criteria |
1. No participants under 13
2. No one who lives outside of the area 3. No residents whose addresses have not been randomly chosen |
| Anticipated start date | 01/03/2008 |
| Anticipated end date | 01/12/2012 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 4000 |
| Interventions |
Target number of participants:
In each wave of the adult survey (at the start and end of the project) there will be 4000 participants (100 in each of the 20 intervention and 20 control areas). In the adolescent survey there will be 60 children in each of the 40 areas in each wave. Interventions: Well London (WL) is the Greater London Authority's flagship project on health supported by NHS London and 20 primary care trusts (PCTs) and boroughs. The project commenced in March 2008 in 20 of the most deprived communities in London with £9.42 million funding from Big Lottery "Wellbeing" Fund (BLF) delivering complex interventions over 3.5 years to address poor diet, insufficient physical activity and poor mental wellbeing. Interventions are based on existing best practice, designed and implemented with community participation. Initially two areas (LSOAs) in each of 20 London boroughs were chosen as being in the most deprived 10% of all London LSOAs using the Index of Multiple Deprivation. One of the two was then randomly chosen for interventions and the remaining area was left as control with no spending. The two areas do not adjoin each other to avoid any 'spill-over' of the intervention. The control cluster is therefore 'matched' to the intervention area in that it is in the same borough and that it is similarly deprived. Health indicators in matched clusters will be compared at start and end of WL. Quantitative surveys will take place in both intervention and control clusters to evaluate interventions and the approach taken to participatory design and provide evidence on appropriateness of extending this model to other deprived areas. Interventions are drawn from a set of possible projects. The exact mix will be decided upon in each area depending on what local people identify as priorities and what facilities and services are already provided. The set of possible projects include: 1. Healthy Spaces a project to improve the quality of public space in the area to encourage physical activity 2. Active Living, residents will be provided with maps informing them of local resources for making healthy choices e.g. farmer's markets, open space 3. Be Creative Be Well, supporting and facilitating local cultural projects to foster social networks and social capital 4. Buywell, a set of interventions to improve access to healthy food choices in the local area 5. Changing Minds, people with experience of mental ill-health will be recruited to raise awareness of mental health and promote understanding of its impact 6. DIY Happiness, using humour and creativity and based on positive psychology theories activities will aim to reduce impact of stress and increase psychological resources 7. Eatwell aims to improve diet and nutrition by raising awareness of importance of diet to physical and mental health and making healthy eating easier and more attractive Full details of the projects are on the Well London website at http://www.londonshealth.gov.uk/well_london.htm. The interventions are due to start in all intervention areas in 2008 and continue throughout the four year period with roughly equal spend on project activity in each year. The follow-up is a repeat of the adult and adolescent surveys at the end of the interventions in 2012. The surveys will be of a randomly selected sample of addresses within the intervention and control areas. We are not attempting in 2012 to re-contact those who took part in the survey in 2008. |
| Primary outcome measure(s) |
Adult survey:
Changes in levels of mental health (MH), physical activity, healthy eating between baseline and follow up. MH is measured using the 12-item General Health Questionnaire (GHQ-12) and positive psychology scale. Also questions on social networks and social capital are drawn from the UK Government Harmonised question set on social capital. Physical activity is measured using the International Physical Activity Questionnaire. Diet is measured using questions from the Health Survey for England on items consumed in the previous 24-hour period. Other questions on healthy quality of life and demographic and social characteristics are also collected. Child survey: Adolescent questionnaire measures emotional behavioural status using 2001 Child Behaviour checklist, self -esteem will be measured using Rosenberg self-esteem scale, the Child Health and Illness Profile - adolescent edition will be used to measure overall health status and the Child's Attitudes to Physical Activity Scale will assess attitudes to PA. Again the measures will be taken at baseline and follow-up in control and intervention areas. |
| Secondary outcome measure(s) | Questionnaires will not only measure levels of healthy behaviour around diet, physical activities and mental well being but perceived barriers or constraints to identify areas where resources can be targeted. |
| Sources of funding |
1. Big Lottery Fund (UK) - funding interventions
2. The Wellcome Trust (UK) (grant ref: 083679) - funding evaluations and full randomised cluster trial Staff costs partially met by: 3. University of East London (UK) 4. University of Westminster (UK) 5. London School of Hygiene and Tropical Medicine (LSHTM) (UK) 6. Loughborough University (UK) |
| Trial website | http://www.londonshealth.gov.uk/well_london.htm |
| Publications | |
| Contact name | Dr Martin Wall |
| Address |
Institute of Health and Human Development
University of East London University House Romford Road |
| City/town | London |
| Zip/Postcode | E15 4LZ |
| Country | United Kingdom |
| Tel | +44 (0)20 8223 4294 |
| m.wall@uel.ac.uk | |
| Sponsor | University of East London (UK) |
| Address |
c/o Tim Brooks
The Graduate School Docklands Campus 4 - 6 University Way |
| City/town | London |
| Zip/Postcode | E16 2RD |
| Country | United Kingdom |
| Tel | +44 (0)20 8223 2421 |
| t.brooks@uel.ac.uk | |
| Sponsor website: | http://www.uel.ac.uk/ |
| Date applied | 08/04/2008 |
| Last edited | 10/04/2008 |
| Date ISRCTN assigned | 10/04/2008 |
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